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510(k) K210143

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) by Foshan Nanhai Plus Medical Co, Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2021
Date Received
January 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Foshan Nanhai Plus Medical Co, Ltd.

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  • K133075 — Plus Surgical Gowns (EO Sterilized), PMGB-XXX (June 24, 2015)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)

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